Dietary Reversal of the Reprometabolic Syndrome
- Conditions
- Obesity & OverweightInfertility, Female
- Registration Number
- NCT07227766
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
This study proposes to test the specific question that a eucaloric, low-fat diet given to women with obesity will result in an increase in reproductive hormones.
- Detailed Description
This an open-label, multi site study in pre-menopausal women aged 18-40 years old with a history of regular menstrual cycles (25-35 days long) of high BMI. The objective of the study will be to determine the effects of a one month long, eucaloric low-fat diet on reproductive hormone levels in women with a high BMI. The study will occur over 4 menstrual cycle (approximately 4 months). During the study the participants will have a pre-diet cycle where no food will be consumed, an on-diet cycle where the customized low-fat diet will be consumed, and two post diet cycles. First morning voided urine will be collected during all four cycles along with 3 blood draws during the study. Participants will be asked to use a reliable barrier method of birth control or abstain from intercourse during the study.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 30
- Normal TSH and prolactin
- Regular menstrual cycles every 25-40 days
- No history of chronic disease affecting hormone production, metabolism or clearance
- No use of reproductive hormones, or medications/supplements known to impact them, within 3 months of enrollment
- Use of a reliable method of contraception (female or male partner sterilization, IUD, abstinence, diaphragm or cervical cap)
- Normal ovarian reserve (AMH of 0.5ng/ml or greater)
- Normal testosterone levels at screening or absence of clinical evidence of hyperandrogenemia (acne, facial hirsutism [defined as Ferriman-Gallwey score>8] or alopecia)
- Baseline dietary assessment indicative of 28% or less daily calories from fat
- Inability to comply with the protocol (many meals per week eaten outside of the home, frequent travel)
- Pregnancy or planned pregnancy within next 6 months at time of screening
- HbA1C >6.5%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Urinary Pregnadiol Glucouronide concentration in ug/mg creatinine From enrollment for 4 months post enrollment
- Secondary Outcome Measures
Name Time Method Amount of Urinary estrogen From enrollment to 4 months Urinary estrogen concentration in microgram/mg of Creatinine
Trial Locations
- Locations (1)
University of Colorado School of Medicine
🇺🇸Aurora, Colorado, United States
University of Colorado School of Medicine🇺🇸Aurora, Colorado, United States